510(k) K240509
- Device
- STAR Apollo? Mapping System
- Applicant
- Rhythm AI, Ltd.
- 510(k) number
- K240509
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-26
- Date received
- 2024-02-22
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Linda D'Abate
- Address
- One London Wall, 6th Floor London GB EC2Y 5EB EC2Y 5EB
FDA Registration Numbers#
- 3045891669
- 2648045
- 3009600098
- 3033959233
- 3008729547
- 3013581838
- 3006087789
- 2030404
- 3002672225
- 1650907
- 3003768277
- 2183926
- 3017638059
- 3009499478
- 2438852
- 3005334138
- 1054713
- 3004016520
- 3008329188
- 2024168
- 3004006614
- 3010155648
- 3010390468
- 3017233611
- 3015151147
- 3004594159
- 3016674095
- 3017060084
- 3026523691
- 3012520654
- 3007029079
- 3007208829
- 3018940143
- 3016618143
- 3010342616
- 3012359877
- 2246552
- 3013679558
- 1320894
- 3017401510
- 3004091615
- 3009254201
- 3014848734
- 3004977335
- 9610816
- 3013943846
- 3016678045
- 3008203003
- 3003971136
- 3032916632
- 3004415095
- 3008483389
- 3008093809
- 3013403214
- 3010716438
- 3021769057
- 3021016555
- 3004972322
- 3007603826
- 3013627970
- 1058584
- 3003616071
- 1527715
- 3000126629
- 3012619193
- 2134213
- 3010273872
- 3007770164
- 3017684005
- 2133772
- 1058031
- 3013596024
- 1218950
- 3013300026
- 3014272734
- 3012032144
- 3004105270
- 3018783526
- 3031786139
Source Documents#
Other 510(k) Records For Product Code DQK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263380 | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | 2026-10-23 |
| K263016 | Intra-Operative Positioning System (IOPS) and IOPS Visionary System | Centerline Biomedical | 2026-10-01 |
| K254255 | S-Patch CardioAI | Wellysis Corp. | 2026-09-25 |
| K261729 | EnSite™ X EP System | Abbott Medical | 2026-09-17 |
| K253692 | AVVIGO™+ Multi-Modality Guidance System | Boston Scientific | 2026-08-21 |
| K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026-08-21 |
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | 2026-07-26 |
| K262006 | EnSite™ X EP System | Abbott Medical | 2026-07-15 |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | 2026-07-09 |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | 2026-07-02 |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026-06-30 |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | 2026-06-12 |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | Centerline Biomedical | 2026-06-10 |
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | 2026-05-29 |
| K260212 | EnSite™ X EP System | ABBOTT MEDICAL | 2026-04-20 |